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Aceclofenac enteric-coated pellet capsule and preparation method thereof

A technology of enteric-coated pellets and aceclofenac, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, and drug delivery, can solve problems such as indigestion, gastrointestinal irritation, and abdominal discomfort, and achieve guaranteed The effects of roundness, stability and uniformity

Active Publication Date: 2014-08-06
PUYANG ZHONGYI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is slightly soluble in water, which can easily cause adverse reactions such as indigestion and abdominal discomfort, and is irritating to the gastrointestinal tract.
In order to give full play to its therapeutic effect and reduce the impact of adverse reactions on patients, the Chinese invention patent application CN102824312A has announced the prior art of aceclofenac enteric-coated pellets composition and its preparation method. In this patent application, It prepares aceclofenac and corresponding auxiliary materials into pellet cores with a particle size of about 1.0-1.2mm, and then wraps the coating material. There are problems in the reproducibility of the process, so it is particularly urgent and important to develop aceclofenac new pharmaceutical dosage form

Method used

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  • Aceclofenac enteric-coated pellet capsule and preparation method thereof
  • Aceclofenac enteric-coated pellet capsule and preparation method thereof
  • Aceclofenac enteric-coated pellet capsule and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0070] Embodiment 1 Preparation of aceclofenac enteric-coated pellet capsules of the present invention

[0071] The prescription is composed of the following components by weight (unit: mg):

[0072] a. Blank ball core

[0073] Sucrose 35

[0074] starch 20

[0075] Microcrystalline Cellulose 15

[0076] b. The main drug layer

[0077]

[0078] c. Isolation layer

[0079] Micronized silica gel 18

[0080] Hypromellose E5 2

[0081] d. Enteric coating layer

[0082]

[0083] Preparation:

[0084] (1) Preparation of blank ball cores: prepare 50% sucrose aqueous solution as a binder, and prepare blank ball cores by weighing the prescribed amount of starch and / or microcrystalline cellulose, and set aside;

[0085] (2) Wrapping the main drug layer: take the prescribed amount of emulsifier, and prepare it into a 5% emulsifier aqueous solution. At a temperature of 20°C and a stirring speed of 400 to 1200 rad / min, add the prescribed amount of disintegrant, Pre-emulsify...

Embodiment 2

[0089] Embodiment 2 Preparation of aceclofenac enteric-coated pellet capsules according to the present invention

[0090] The prescription is composed of the following components by weight (unit: mg):

[0091] a. Blank ball core

[0092] Sucrose 35

[0093] Microcrystalline Cellulose 35

[0094] b. The main drug layer

[0095]

[0096] c. Isolation layer

[0097] Micronized silica gel 12

[0098] Hypromellose E5 3

[0099] d. Enteric coating layer

[0100]

[0101] Preparation:

[0102] (1) Preparation of blank ball cores: prepare 50% sucrose aqueous solution as a binder, and prepare blank ball cores by weighing the prescribed amount of starch and / or microcrystalline cellulose, and set aside;

[0103] (2) Wrapping the main drug layer: take the prescribed amount of emulsifier, and prepare it into a 5% emulsifier aqueous solution. At a temperature of 20°C and a stirring speed of 400 to 1200 rad / min, add the prescribed amount of disintegrant, Pre-emulsify for 0.5h ...

Embodiment 3

[0107] Embodiment 3 Preparation of aceclofenac enteric-coated pellet capsules according to the present invention

[0108] The prescription is composed of the following components by weight (unit: mg):

[0109] a. Blank ball core

[0110] Sucrose 30

[0111] Starch 50

[0112] b. The main drug layer

[0113]

[0114] Monoglyceride diacetyl tartrate 10

[0115] c. Isolation layer

[0116] Micronized silica gel 20

[0117] Hypromellose E5 4

[0118] d. Enteric coating layer

[0119]

[0120] Preparation:

[0121] (1) Preparation of blank ball cores: prepare 50% sucrose aqueous solution as a binder, and prepare blank ball cores by weighing the prescribed amount of starch and / or microcrystalline cellulose, and set aside;

[0122] (2) Wrapping the main drug layer: take the prescribed amount of emulsifier, and prepare it into a 5% emulsifier aqueous solution. At a temperature of 20°C and a stirring speed of 400 to 1200 rad / min, add the prescribed amount of disintegrant...

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Abstract

The invention relates to an aceclofenac enteric-coated pellet capsule and a preparation method thereof, and belongs to the technical field of a drug preparation. The aceclofenac enteric-coated pellet capsule is prepared from aceclofenac enteric-coated pellets filling in a capsule shell. The aceclofenac enteric-coated pellet capsule is simple in preparation method, low in labor intensity, applicable to industrial production, beneficial to environmental protection, small in gastrointestinal stimulation on a sufferer, high in bioavailability, good in stability and the like.

Description

technical field [0001] The invention relates to a pellet capsule and a preparation method thereof, in particular to an aceclofenac enteric-coated pellet capsule and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] The chemical name of aceclofenac is 2-((2,6-dichlorophenyl)amino)phenylacetoxyacetic acid, which is a new type of powerful antipyretic, analgesic and anti-inflammatory non-steroidal drug. It is suitable for the treatment of rheumatoid arthritis, rheumatoid arthritis, osteoarthritis, spondylitis, etc., and is also suitable for pain and fever caused by various diseases. Its mechanism of action is mainly through the inhibition of cyclooxygenase activity, thereby reducing the synthesis of prostaglandins. [0003] Compared with diclofenac, aceclofenac, ketoprofen and indomethacin are safer and more effective. However, it is slightly soluble in water, which can easily cause adverse reactions su...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/216A61P19/02A61P29/00
Inventor 孙树玲何庆国黄永贤李保雷高子彬左文飞李志伟
Owner PUYANG ZHONGYI PHARMA CO LTD
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